1. The Field of the Invention
The present disclosure relates generally to oral care compositions and methods of use, and more particularly, but not necessarily entirely, to a dental maintenance system that integrates multiple cavity protecting products into an integrated and easily implemented oral hygiene kit and system.
2. Description of Related Art
Dental caries is an ecological disease in which the diet, the host and the microbial flora interact over a period of time in such a way as to encourage demineralization of the tooth enamel with resultant caries formation. Dental caries is one of the most common diseases in the world today, and until recently almost everyone in the world had experienced tooth decay in their lifetime. However, today many people are caries free and there has been a forty to sixty percent (40-60%) reduction in the incidence of tooth decay within the Western world. Most developed countries and many non-industrialized countries are now well below the World Health Organization's goal of less than three decayed, missing or filled teeth per twelve-year old child.
Teeth are composed of a thin layer (1-2 mm) of dental enamel, which forms the hard protective coating over each tooth. Teeth consist mainly of calcium, phosphate and other ions in a structure known as “hydroxyapatite.” Dental enamel is porous and is susceptible to acid dissolution during the process of demineralization. This demineralization process is offset by the repair process known as remineralization. Tooth susceptibility to dental caries varies among individuals. Although the reasons for the variation are not fully known, some influences include: (a) the shape, size and order of the teeth that affect the “washing” effects of saliva, which is largely determined by hereditary factors; (b) salivary components which can be critical in controlling dental caries since salivary components affect bacteria, immune status, plaque formation, and enamel structure and can neutralize acids, and therefore saliva has a vital role in the balance between demineralization and remineralization; and (c) enamel structure can be altered by a selection of mineral ions and fluoride, as well as by acid, and the balance between demineralization and remineralization of the enamel determines whether caries will occur.
However, fluoride is toxic. Fluoride's toxic impacts are cumulative, meaning that only fifty percent (50%) of ingested fluoride is excreted through the kidneys, while the remainder accumulates in the body. Fluoride is effective only in its topical application, and not in its systemic application. Humans can have perfectly good teeth without fluoride, as fluoride is not an essential nutrient. It will be appreciated that fluoride may lead to a condition known as dental fluorosis, which is the incomplete development of the dental enamel and is characterized by defective calcification that mottles teeth. Fluoride has been shown to be mutagenic, to cause chromosome damage, and to interfere with enzymes involved in DNA repair. Additionally, fluoride facilitates the uptake of certain damaging metals into the body. Studies have suggested that fluoride can exacerbate certain neurological defects. Fluoride can also interfere with the function of the thyroid gland. Fluoride can also lead to skeletal fluorosis, which mimics the symptoms of arthritis. Therefore, the risks associated with ingested fluoride far outweigh the benefits.
Dental caries, or cavities, are bacterial infections that cause the tooth structure to deteriorate. The compositions disclosed herein fight cavities from their novel use of xylitol in several integrated products. Xylitol is a clinically proven cariostatic sweetener that reduces the ability of cavity-causing bacteria to impact oral health. Because of xylitol's cariostatic attributes, cavities cannot form in its presence. As such, it is a valuable tool in preventing and fighting cavities. While the United States Food and Drug Administration has not approved cavity prevention claims for xylitol, several studies substantiate its efficacy. Some studies even suggest that xylitol may aid in the reversal of certain types of cavities.
The international community has performed most of these studies regarding xylitol's efficacy. Only recently, has the United States dental community begun to embrace xylitol as an effective tool in caries management therapy.
Although more than forty (40) studies demonstrate the impact of xylitol on cavities, two of the most illustrative are highlighted below. Studies such as these lay a strong scientific foundation for the product efficacy assertions of xylitol.
The first study was a 40-month double-blind cohort study of 1,135 school children used to determine the impact of sugar-free gums on the incidences of cavities. As illustrated in FIG. 1, the study reviewed the change in decayed, missing, and/or filled surfaces (DMFS) of subjects in several groups. The group that chewed xylitol gum actually had a reduction in DMFS, while all other groups including no gum, sugar gum, and sugar-free gum saw substantial increases in DMFS. The researchers concluded, a “xylitol-based chewing gum program in basic caries prevention can be substantial.” Makinen K K, Bennett C A, Hujoel P P, Isokangas P J, Isotupa K P, Pape H R Jr, Makinen K K. Xylitol chewing gums and caries rates: a 40-month cohort study. J Dent Res December 1995; 74(12):1904-13.
The second study was a 24-month double-blind study of more than 500 six-year old children used to determine the effect of xylitol on the rehardening of dentine lesions in the primary dentition. As illustrated in FIG. 2, researchers administered xylitol gum, sugar-free gum and no gum to participants who had small cavities. The subjects' cavities were then evaluated to determine if the carious lesions had been rehardened. The researchers found “that high-xylitol content chewing gum usage can retard or arrest rampant dentine caries.” Makinen K K, Hujoel P P, Bennett C A, Isotupa K P, Makinen P L, Allen P. Polyol chewing gums and caries rates in primary dentition: a 24-month cohort study. Caries Res 1996; 30(6):408-17.
The scientific evidence supporting xylitol's dental benefits provides a solid foundation that xylitol products substantially reduce cavities without the use of fluoride. Because xylitol can be used as a direct substitute for sugar, its dental benefits can be derived through a variety of product applications.
There are several xylitol containing compositions known in the art, such as that disclosed in U.S. Pat. No. 5,496,541 (granted Mar. 5, 1996 to Cutler). This reference discloses several dental products employing a ternary surfactant system of poloxamers, anionic polysaccharides, and nonionic cellulose ethers. This reference also includes a mild abrasive plus one or more of the following: xylitol, raw licorice, licorice extract, and glycyrrhizin and its derivatives. This reference also discloses dental products that may comprise fluoride, which is disadvantageous when used in gum, mints, toothpaste, mouthwash, and other dental products that may be ingested because fluoride is toxic and accumulates in the body.
Another xylitol containing composition is disclosed in U.S. Pat. No. 5,900,230 (granted May 4, 1999 to Cutler). This reference discloses several dental products that can be used to treat and prevent periodontal disease. These products contain a mixture of poloxamers, and/or poloxamer congeners, plus xylitol. This reference also teaches dental products that may comprise fluoride, which is disadvantageous when used in gum, mints, toothpaste, mouthwash, and other dental products that may be ingested because fluoride is toxic and accumulates in the body.
U.S. patent Publication No. 2003/0091514 (published May 15, 2003 to Stier) discloses several oral care compositions comprising diglycerol in addition to various other ingredients for flavoring, sweetening, thickening and the like. Similar to the above mentioned references, this reference discloses dental products that may comprise fluoride, which is disadvantageous when used in gum, mints, toothpaste, mouthwash, and other dental products that may be ingested because fluoride is toxic and accumulates in the body.
It is noteworthy that none of the prior art known to applicant provides an effective amount of xylitol used in fluoride-free dental products for promoting oral hygiene as disclosed in detail below. There is a long felt, but unmet, need for such products in the market today that are relatively inexpensive to produce and manufacture, and are therefore readily available to the general public.
The art is thus characterized by several disadvantages that are addressed by the compositions disclosed herein. The present compositions of the present disclosure minimizes, and in some aspects eliminates, the above-mentioned failures, and other problems, by utilizing the methods and compositions described herein.
The features and advantages of the disclosure will be set forth in the description which follows, and in part will be apparent from the description, or may be learned by the practice of the disclosure without undue experimentation. The features and advantages of the disclosure may be realized and obtained by means of the compositions and combinations particularly pointed out herein.